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Health product recall

Liquicheck Diabetes Control (2017-03-03)

Starting date:
March 3, 2017
Posting date:
March 24, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-62786

Affected Products

A. Liquichek Diabetes Control
B. Liquichek Diabetes Control Levels 1, 2 And 3

Reason

Bio-Rad Laboratories Canada Ltd is issuing this recall at the manufacturer's request. The manufacturer has noticed that hemoglobin A1C values can drop progressively over the life of the product. Bio-Rad has revised the data sheets for Liquichek Diabetes Control for hemoglobin A1c under the limitations section. All other assay values for these lots of Liquichek Diabetes Control remain unchanged.

Affected products

A. Liquichek Diabetes Control

Lot or serial number

38531
38531V
38532
38532V
38533
38533V
38541
38542
38543

Model or catalog number

171
172
173
291
292
293

Companies
Manufacturer
Bio-Rad Laboratories
9500 Jeronimo Road
Irvine
92618
California
UNITED STATES

B. Liquichek Diabetes Control Levels 1, 2 And 3

Lot or serial number

38530
38530V
38540

Model or catalog number

172X
292X

Companies
Manufacturer
Bio-Rad Laboratories
9500 Jeronimo Road
Irvine
92618
California
UNITED STATES